The present invention relates to bodies for catheters and sheaths, and to tips for use in conjunction with such catheters and sheaths, as wells as to methods of manufacturing and using the same. More particularly, the present invention relates to splittable and radiopaque bodies and tips, and to methods of manufacturing and using such bodies and tips.
Catheters and sheaths are commonly manufactured with splittable (i.e., peelable or peel-away) type tubular bodies that allow the catheter or sheath to be removed from about an implanted medical device (e.g., pacemaker leads) without disturbing the device. Prior art tubular bodies are formed with peeling grooves that extend longitudinally along the inner or outer circumferential surfaces of their walls in order to make the tubular bodies splittable. Providing such peeling grooves is a difficult and expensive manufacturing process.
Other catheters and sheaths are commonly manufactured with tubular bodies having radiopaque distal tips. Such catheters and sheaths are used in cardiovascular procedures and other medical procedures. The radiopaque distal tip may be viewed within a patient's body via an X-ray fluoroscope or other imaging system, thereby allowing a physician to position the tubular body as required during a procedure.
Prior art tubular bodies with radiopaque distal tips often use precious heavy metals (e.g., gold, platinum, tantalum) to achieve sufficient tip radiopacity. For example, a thin band of a precious heavy metal is imbedded in the distal tip of each such prior art tubular body. As a result, such prior art tubular bodies end up being quite expensive because of the high cost of the precious heavy metals and the labor intensive manufacturing processes used to manufacture such tubular bodies.
Tubular bodies are made from polymeric materials that may not be chemically compatible with the precious metal used to form the radiopaque distal band. As such, the distal band may not adhere to the material matrix of the tubular body, causing potential material separation and a discontinuity in mechanical strength.
Where a tubular body with a radiopaque distal tip also needs to be splittable to allow its removal from a patient without disturbing an implanted medical device, the thin band of precious heavy metal must be provided with a peeling groove that coincides with the peeling groove in the tubular body's wall. This adds further difficulty and expense to an already difficult and expensive manufacturing process.
There is a need in the art for a splittable and/or radiopaque tubular body that utilizes less costly materials, is less labor intensive to manufacture, and is less likely to fail during a medical procedure due to material separation. There is also a need for methods of manufacturing and using such a tubular body.